Pediatric HerniaNCT06735430
Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery
A study testing Ciprofol and Propofol in people with Pediatric Hernia and Laparoscopic Surgery, run by Tongji Hospital at 1 site in China.
Trial summary
a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pediatric Hernia, Laparoscopic Surgery, Appendicitis, Surgery
- What is being tested?
- Ciprofol and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- laparoscopic surgery under general anesthesia
Who cannot join
- Known allergies to propofol and ciprofol,
- Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders;
- uncooperate with peripheral venipuncture and catheterization;
- History of acute upper respiratory tract infection in the past 2 weeks;
- With severe respiratory, circulation, liver and kidney insufficiency;
- Body mass index (BMI) of 30 kg/m² or 15 kg/m²;
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- Known long-term use of sedative drugs;
- ASAⅢ grade or above;
- recent participation in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery: a Prospective, Double-blind, Randomized Controlled, Non Inferiority Clinical Trial
a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.
Read the detailed description
Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.
- Being tested
- Ciprofol, Propofol
- Keywords
- Ciprofol, Propofol, Total Intravenous Anesthesia, Children
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))
PropofolDrug
Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol | Experimental | Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h)) Receives: Drug: Ciprofol |
| Propofol | Other | Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h)) Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
Time interval between drug withdrawal and removal of the tracheal catheter
Measured: up to 1 hour
Secondary outcomes (5)
Aldrete Score
In the PACU, Investigators using Aldrete score scale(0- 10 points)
Measured: up to 2 hours
Emergence Agitation
In the PACU, Investigators assessed emergence delirium using PAED 0-20 points)
Measured: up to 2 hours
Postoperative Pain
use the FLACC pain score(0- 10 points)
Measured: 24 hours
Postoperative nausea and vomiting
Investigators assessed postoperative nausea and vomiting BARF scale(0-10points)
Measured: 24 hours
satisfaction degree
Child and/or Parent Satisfaction Survey (0-10 points)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start9 Mar 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric HerniaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- mujun Chang, Dr., Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735430
- Sponsor's protocol ID
- Tongji Hospital-20241204
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery: a Prospective, Double-blind, Randomized Controlled, Non Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06735430
- Acronym / sponsor ID
- Tongji Hospital-20241204
- Keywords
- Ciprofol, Propofol, Total Intravenous Anesthesia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.
Detailed description
Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol | Experimental | Drug: CiprofolCiprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h)) |
| Propofol | Other | Drug: PropofolPropofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h)) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- laparoscopic surgery under general anesthesia
Key exclusion criteria (9 listed)
- Known allergies to propofol and ciprofol,
- Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders;
- uncooperate with peripheral venipuncture and catheterization;
- History of acute upper respiratory tract infection in the past 2 weeks;
- With severe respiratory, circulation, liver and kidney insufficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofolCiprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h)) | Drug | Ciprofol |
| PropofolPropofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h)) | Drug | Propofol |
Primary outcome
Extubation time
Time frame: up to 1 hour
Time interval between drug withdrawal and removal of the tracheal catheter
5 secondary outcomes
Aldrete Score
Time frame: up to 2 hours
Emergence Agitation
Time frame: up to 2 hours
Postoperative Pain
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 hours
satisfaction degree
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mujun Chang, Dr. study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofol and Propofol in people with Pediatric Hernia and Laparoscopic Surgery, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation time (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.